NEW YORK (Reuters Health) – In a phase 3 study, the ranibizumab biosimilar SB11 demonstrated equivalent efficacy and similar safety and immunogenicity profiles compared with ranibizumab for patients with neovascular age-related macular degeneration (nAMD).
Specifically, said study coauthor Dr. Neil Bressler of Johns Hopkins Hospital in Baltimore and Editor-in-Chief of JAMA Ophthalmology, “The results showed equivalent efficacy for visual acuity outcomes at eight weeks and anatomic outcomes at four weeks, which were the endpoints required by the U.S. FDA (visual acuity) and the EMA (OCT central subfield thickness), respectively, to show equivalent efficacy for biosimilars to anti-VEGF agents used to treat nAMD.”
“Also, the safety and immunogenicity profiles of SB11 appeared similar to that of ranibizumab,” he said. “The regulatory agencies likely would conclude that these results support that physicians should have confidence to prescribe these biosimilar agents for nAMD in situations in which they consider using ranibizumab.”
“Physicians may have a reluctance to consider a biosimilar because of a lack of experience of using biosimilars,” he noted. “However, there is no scientific evidence at this time to support such a reluctance.”
As reported in JAMA Ophthalmology, Dr. Bressler and colleagues did a preplanned interim analysis of the equivalence study after the 705 randomized participants (mean age, 74; 57% women) completed the week 24 assessments.
The study was conducted in 75 centers in nine countries from 2018-2019, and the interim analysis was performed in May 2019. Participants received an intravitreous injection of SB11 or ranibizumab, 0.5 mg, every four weeks through week 48 (total of 13 doses for those who completed the study).
Least-squares mean changes in central subfield thickness from baseline at week four were −108 micrometers for SB11 versus −100 micrometers for ranibizumab, with an adjusted difference of −8 micrometers.
Least-squares mean changes in best-corrected visual acuity from baseline at week eight were 6.2 letters in the SB11 group versus 7.0 letters in the ranibizumab group, for an adjusted treatment difference of −0.8 letter.
Incidences of treatment-emergent adverse events were similar for SB11 and ranibizumab (66% vs. 66.9%), including serious treatment-emergent adverse events (12.6% vs. 12.4%) and treatment-emergent adverse events leading to drug discontinuation (2.3% vs. 1.4%).
Immunogenicity was low, with a cumulative incidence of anti-drug antibodies up to week 24 of 3% in the SB11 group and 3.1% in the ranibizumab group.
Dr. Bressler said, “There may be greater confidence to overcome (prescribing) reluctance if physicians have longer term safety and efficacy results comparing this biosimilar to ranibizumab. Such results were presented as a poster at American Academy of Ophthalmology meeting in November.” (https://bit.ly/37muWDl ).
“Hopefully,” he added, “these results will appear in the peer-reviewed literature within the next six months to provide this confidence, and hopefully these results, in general, will be looked upon by ophthalmologists and others in the scientific community and the public that a biosimilar, appropriately approved by regulatory agencies, will provide more choices for healthcare providers to consider when managing…major public health problems such as AMD and diabetic retinopathy, in the U.S. and elsewhere around the world.”
Dr. Shiji Patel, Associate Fellowship Director, Vitreoretinal Diseases and Surgery at Vanderbilt Eye Institute in Nashville, commented by email to Reuters Health, “Given the large number of patients enrolled over multiple sites and the methodologic rigor with which the study was conducted, the results are very encouraging.”
“Anti-VEGF agents account for a significant portion of the CMS Medicare Budget and have been a target for cost-savings,” he said. “It will be interesting to see what the cost of this product will be.”
Like Dr. Bressler, he noted that results affirming the current study results were recently presented. “However,” he said, “we don’t have long-term data or durability data for extension past Q4 injections.”
The study was funded by Samsung Bioepis, Incheon, Republic of Korea. One coauthor is an employee and seven coauthors have received fees from the company. Dr. Bressler received grants from the company to Johns Hopkins University during the conduct of the study.
SOURCE: https://bit.ly/39ByaFA JAMA Ophthalmology, online November 19, 2020.